Form FDA 1932 Form FDA 1932 Veterinary Adverse Drug Reaction; Lack of Effectiveness

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VETERINARY ADVERSE DRUG REACTION,
LACK OF EFFECTIVENESS,
PRODUCT DEFECT REPORT

FOOD AND DRUG ADMINISTRATION
7500 Standish Place (HFV-210), Room N403
Rockville, MD 20855

Form Approved: OMB No. 0910-0284
Expiration Date: June 30, 2006

(Forward to address at left. Attach all correspondence that pertains to this reaction)

Public reporting burden for this collection of information is estimated to average 2 hour per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to:
An agency may not conduct or sponsor, and a person is not required
Food and Drug Administration
to respond to, a collection of information unless it displays a currently
7500 Standish Place (HFV-210), Room N403
valid OMB control number.
Rockville, MD 20855

NOTE: This report is required by law (21 CFR 510.300). Failure to report can result in withdrawal of approval of the application.
1. REPORT SOURCE AND ADDRESS (Mfr., Distr.)

2a. DATE REPORT RECEIVED

3a. TYPE OF REPORT
3-day Alert

b. DATE SENT TO FDA
3b.
c.
4. NAME, ADDRESS AND PHONE NO. OF ATTENDING VETERINARIAN
(In confidence)

15-day Alert

Periodic Report

NUMBER OF DAYS BETWEEN 2a AND b:

Initial Report
Follow Up Report
Of (Give Date)

5. NAME OR CASE IDENTIFICATION OF OWNER
(In confidence)

Name:
Street Address:
City:

State:

ZIP:

Phone No. ( __ __ __ ) __ __ __ - __ __ __
6. TRADE NAME AND GENERIC NAME(S) OF ACTIVE INGREDIENT(S)
(Include dosage form and strength - Ex., tab, 500 mg.)

7a. NAME OF MANUFACTURER

8. LOT NUMBER(S)

10. DATE(S) OF ADMINISTRATION

b. NADA NO.
9. DOSAGE ADMINISTERED AND ROUTE
(Ex. 250 mg., q 12 h, p.o.)

11. ILLNESS/REASON FOR USE OF THIS DRUG

12. DRUG WAS ADMINISTERED BY
OWNER, OTHER

VETERINARIAN, STAFF
NUMBER OF ANIMALS IN THIS INCIDENT
13.
a. TREATED WITH DRUG
b. REACTED

14.
a. SPECIES

c. DIED

REACTING ANIMALS
b. BREED

d. WEIGHT

c. AGE

15. CONCOMITANT MEDICAL PROBLEMS

e. SEX
FEMALE
16. OVERALL STATE OF HEALTH AT TIME OF REACTION
GOOD

FAIR

POOR

CRITICAL

18.

MALE

PREGNANT

NEUTERED

17. DID ANY NEW ILLNESS DEVELOP OR DID INITIAL DIAGNOSIS CHANGE AFTER
SUSPECT DRUG STARTED?
YES (Explain)

NO

CONCOMITANT DRUGS ADMINISTERED
NAME OF DRUG

ROUTE

DOSAGE REGIMEN

DATE(S) OF ADMINISTRATION

FOR FDA USE ONLY
COMMENT
1.
2.
3.
4.
5.
6.
T.

D

NAI

PR

AI

PO

AP

R

AL

NC

I.L.

CR

CONT

FORM FDA 1932 (9/03)

PSC Media Arts (301) 443-1090

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REACTION DATA
19. DESCRIBE SUSPECTED ADVERSE REACTION: INCLUDE ALL SIGNS, RESULTS OF PERTINENT LAB TESTS, NECROPSY RESULTS, POSSIBLE
CONTRIBUTING FACTORS, ETC. ALSO, INCLUDE IN THIS SECTION PRODUCT INEFFECTIVENESS AND PRODUCT DEFECTS SUCH AS CRACKED
TABLETS, CLOUDY SOLUTION, ETC.

20a. ATTENDING VETERINARIAN’S LEVEL OF SUSPICION THAT DRUG
CAUSED REACTION
HIGH

MEDIUM

LOW

20b. WAS THERE EXTRA LABEL USE (ELU) INVOLVED?

NO ATTENDING VET.

NO

YES (Explain)

21. LENGTH OF TIME BETWEEN LAST ADMINISTRATION OF SUSPECT DRUG AND
ONSET OF REACT

22. DATE OF ONSET
(Mo., day, yr.)

23. DURATION OF REACTION
(Hrs., days, etc.)

24. WAS THE ADVERSE REACTION TREATED?

25. OUTCOME OF REACTION TO DATE
DIED (Give date)

NO

YES (Describe treatment)

REMAINS UNDER TREATMENT
ALIVE WITH SEQUELAE
RECOVERED
UNKNOWN

26. WHEN REACTION APPEARED, TREATMENT WITH SUSPECT
DRUG:
HAD ALREADY BEEN COMPLETED
CONTINUED

DISCONTINUED DUE TO THE REACTION
DISCONTINUED, REPLACE WITH ANOTHER DRUG
DISCONTINUED, REINTRODUCED LATER

STOPPED

AND THE
REACTION

RECURRED
OTHER (Explain)

CONTINUED AT ALTERED DOSE
OTHER (Explain)

27. HAD ANIMAL(S) BEEN PREVIOUSLY EXPOSED TO THIS DRUG?
NO

YES

UNKNOWN

NO

YES

UNKNOWN

NO

YES

UNKNOWN

28. DID ANIMAL(S) PREVIOUSLY REACT TO THIS DRUG?

29. HAD ANIMAL(S) PREVIOUSLY REACTED TO OTHER DRUGS?

(If yes, give drug(s) and reaction if known)

30. HAS THE ATTENDING VETERINARIAN SEEN SIMILAR REACTIONS TO THIS DRUG IN ANY OTHER ANIMALS?
NO

YES (Describe treatment)

31. NAME AND TITLE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY
OF REPORTED INFORMATION (Type or print)

32. SIGNATURE OF INDIVIDUAL RESPONSIBLE FOR ACCURACY OF REPORTED
INFORMATION

FORM FDA 1932 (9/03)

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